Radiopharm Theranostics Receives IND approval from US FDA to Initiate Phase I Therapeutic Clinical Study to target B7H3 with Betabart (RV-01)
Radiopharm Theranostics (NASDAQ:RADX) has received FDA clearance for its Investigational New Drug (IND) application for Betabart (RV-01), a Lu177-B7H3 monoclonal antibody targeting aggressive solid tumors. The company plans to initiate its first-in-human Phase 1 clinical trial in Q4 2025.
RV-01, developed through a joint venture with MD Anderson Cancer Center, is designed with high affinity for the 4Ig isoform of B7H3, which is highly expressed in tumors but not in healthy tissues. The drug's hepatic clearance pathway and shortened half-life may offer advantages over other radiotherapeutics, potentially minimizing hematological toxicities and kidney-related side effects.
Radiopharm Theranostics (NASDAQ:RADX) ha ottenuto l'autorizzazione dalla FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) relativa a Betabart (RV-01), un anticorpo monoclonale Lu177-B7H3 che mira a tumori solidi aggressivi. L'azienda prevede di avviare la sua prima sperimentazione clinica di Fase 1 sull'uomo nel Q4 2025.
RV-01, sviluppato in collaborazione con il MD Anderson Cancer Center, è progettato con alta affinità per l'isoforma 4Ig di B7H3, altamente espressa nei tumori ma non nei tessuti sani. Il percorso di eliminazione epatica e la ridotta emivita del farmaco potrebbero offrire vantaggi rispetto ad altri radioterapici, riducendo potenzialmente le tossicità ematologiche e gli effetti collaterali renali.
Radiopharm Theranostics (NASDAQ:RADX) ha recibido la aprobación de la FDA para su solicitud de Nuevo Fármaco en Investigación (IND) para Betabart (RV-01), un anticuerpo monoclonal Lu177-B7H3 dirigido a tumores sólidos agresivos. La compañía planea iniciar su primer ensayo clínico de Fase 1 en humanos en el Q4 2025.
RV-01, desarrollado en colaboración con el MD Anderson Cancer Center, está diseñado con alta afinidad para la isoforma 4Ig de B7H3, que se expresa fuertemente en tumores pero no en tejidos sanos. La vía de eliminación hepática y la vida media reducida del fármaco podrían ofrecer ventajas sobre otros radioterapéuticos, minimizando potencialmente las toxicidades hematológicas y los efectos secundarios renales.
Radiopharm Theranostics (NASDAQ:RADX)는 공격적인 고형 종양을 표적으로 하는 Lu177-B7H3 단클론 항체인 Betabart (RV-01)에 대한 임상시험용 신약(IND) 신청에 대해 FDA 승인을 받았습니다. 회사는 2025년 4분기에 최초 인간 대상 1상 임상시험을 시작할 계획입니다.
MD Anderson 암센터와의 합작 투자로 개발된 RV-01은 종양에서 높게 발현되지만 정상 조직에서는 발현되지 않는 B7H3의 4Ig 아이소폼에 대한 높은 친화성을 갖도록 설계되었습니다. 약물의 간 배설 경로와 짧은 반감기는 다른 방사성 치료제에 비해 장점을 제공하여 혈액학적 독성과 신장 관련 부작용을 최소화할 수 있을 것으로 기대됩니다.
Radiopharm Theranostics (NASDAQ:RADX) a obtenu l'autorisation de la FDA pour sa demande de nouveau médicament expérimental (IND) concernant Betabart (RV-01), un anticorps monoclonal Lu177-B7H3 ciblant les tumeurs solides agressives. La société prévoit de lancer son premier essai clinique de phase 1 chez l'humain au 4e trimestre 2025.
Développé en partenariat avec le MD Anderson Cancer Center, RV-01 est conçu avec une forte affinité pour l'isoforme 4Ig de B7H3, très exprimée dans les tumeurs mais pas dans les tissus sains. La voie d'élimination hépatique et la demi-vie réduite du médicament pourraient offrir des avantages par rapport à d'autres radiothérapies, minimisant potentiellement les toxicités hématologiques et les effets secondaires rénaux.
Radiopharm Theranostics (NASDAQ:RADX) hat die FDA-Zulassung für seinen Antrag auf ein Investigational New Drug (IND) für Betabart (RV-01) erhalten, einen Lu177-B7H3 monoklonalen Antikörper, der auf aggressive solide Tumoren abzielt. Das Unternehmen plant, seine erste klinische Phase-1-Studie am Menschen im 4. Quartal 2025 zu starten.
RV-01, entwickelt in Zusammenarbeit mit dem MD Anderson Cancer Center, ist mit hoher Affinität für die 4Ig-Isoform von B7H3 konzipiert, die in Tumoren stark exprimiert wird, jedoch nicht in gesundem Gewebe. Der hepatische Eliminationsweg und die verkürzte Halbwertszeit des Medikaments könnten Vorteile gegenüber anderen Radiotherapeutika bieten und potenziell hämatologische Toxizitäten sowie nierenspezifische Nebenwirkungen minimieren.
- FDA clearance received for Phase 1 clinical trial initiation
- First-in-class targeted radiopharmaceutical with unique hepatic clearance mechanism
- Strong affinity and selectivity for 4Ig isoform of B7H3, potentially improving tumor targeting
- Joint venture partnership with prestigious MD Anderson Cancer Center
- Early-stage development with no clinical data yet available
- Clinical trials not expected to begin until Q4 2025
Insights
FDA approval for Radiopharm's B7H3-targeting radiopharmaceutical marks significant milestone, enabling first human trials of potentially differentiated cancer therapy.
The FDA's clearance of Radiopharm Theranostics' IND for Betabart (RV-01) represents a critical regulatory milestone that officially allows the company to begin human clinical trials. This Lu177-labeled monoclonal antibody is designed to target the 4Ig isoform of B7H3, a protein highly expressed in aggressive tumors but minimally present in healthy tissues—creating an ideal therapeutic window.
What makes this candidate particularly promising from a mechanistic perspective is its hepatic clearance pathway. Unlike radiopharmaceuticals cleared through the kidneys (which can cause nephrotoxicity), RV-01's liver-based elimination could potentially reduce radiation damage to sensitive organs while maintaining tumor-targeting efficacy. The liver's natural radio-resistance serves as a biological shield against damage from the therapeutic isotope.
The antibody's selectivity for the 4Ig isoform of B7H3 is another key differentiator. By specifically binding this tumor-associated variant while avoiding the soluble 2Ig isoform found in circulation, RV-01 may achieve superior tumor targeting while minimizing off-target effects and preventing immune complex formation in the bloodstream.
B7H3 represents an increasingly validated target in oncology, with overexpression associated with tumor aggressiveness and poor outcomes across multiple cancer types. This IND clearance positions Radiopharm to advance a first-in-class targeted radiopharmaceutical against this promising target, with patient dosing expected to begin in Q4 2025.
Lu177-B7H3 monoclonal antibody is first in class targeted radiopharmaceutical in development against the 4lg subtype of B7-H3
On track to initiate first-in-human study of RV-01 in solid tumors in 4Q25
SYDNEY, July 28, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has provided clearance of the Company’s Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues.
“FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center,” said Riccardo Canevari, CEO and Managing Director. “RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.”
“Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumors while potentially minimizing adverse effects such as hematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity,” noted Dimitris Voliotis, M.D., Chief Medical Officer of Radiopharm Theranostics.
“The high affinity and selectivity of RV-01 for the 4Ig isoform of B7H3 allows the antibody to bypass the soluble 2Ig isoform in the blood, boost binding of the radiopharmaceutical to tumor targets and avoid the formation of immune complexes in circulation,” noted David Piwnica-Worms, M.D., Ph.D., Professor, MD Anderson Cancer Center, and scientific co-founder of Radiopharm Ventures.
B7-H3 is an immune checkpoint molecule that is overexpressed across several tumor types and has emerged as a compelling target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumor aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumors.
About RV-01
RV-01 is the first radiopharmaceutical therapeutic agent developed by Radiopharm Ventures, the Joint Venture formed between Radiopharm Theranostics and MD Anderson Cancer Center (MDACC). RV-01 is a 177Lutetium-conjugated therapeutic that targets B7-H3, an immune checkpoint molecule that is overexpressed in several tumor types. Multiple preclinical studies with RV-01 have shown tumor shrinkage and prolonged survival in animals treated with the radiotherapeutic agent. RV-01 has received IND-clearance from the U.S. FDA and plans to initiate a first-In-human Phase 1 study in the second half of 2025.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX). The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
Authorized on behalf of the Radiopharm Theranostics Board of Directors by Executive Chairman Paul Hopper.
For more information:
Investors:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Anne Marie Fields
Precision AQ (formerly Stern IR)
E: annemarie.fields@precisionaq.com
Media:
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
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Website – https://radiopharmtheranostics.com/
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LinkedIn – https://www.linkedin.com/company/radiopharm-theranostics/
InvestorHub – https://investorhub.radiopharmtheranostics.com/
FAQ
What is the significance of RADX's FDA IND approval for Betabart (RV-01)?
How does Radiopharm's RV-01 differ from other cancer treatments?
When will RADX begin clinical trials for Betabart?
What types of cancer does RADX's Betabart target?
What is the partnership between RADX and MD Anderson Cancer Center?
